Apparatus for closing vascular puncture

ABSTRACT

A method and apparatus for closing a vascular wound includes a guidewire and/or other surgical implement extending from the wound. A hemostatic material is advanced over the surgical implement and into contact with an area of the blood vessel surrounding the wound. The surgical implement is removed. Blood soaks the hemostatic material, and blood clotting is facilitated by the hemostatic agent within the material. A sealing layer of adhesive can be applied to the hemostatic material, confining the blood flow to the material. The vascular puncture wound is sealed by natural blood clot formation.

RELATED APPLICATIONS

This application claims priority as a divisional application of U.S.application Ser. No. 09/921,158, now U.S. Pat. No. 6,890,342, which wasfiled on Aug. 1, 2001, which application claims priority to U.S.Application Ser. No. 60/222,525, which was filed on Aug. 2, 2000. Theentireties of each of the priority applications are hereby incorporationby reference.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention generally relates to a system that facilitatesclosure of openings in blood vessels. More specifically, the presentdevice delivers a hemostatic material to the opening to facilitatesealing of the blood vessel wound.

2. Description of the Related Art

In many medical procedures, it is necessary to locate an opening intissue so that some form of treatment, diagnosis or revision, can beapplied to that opening. For example, in order to perform transluminalballoon angioplasty, an opening must be created in an artery in order toinsert a balloon. This opening must later be closed.

Transluminal balloon angioplasty is used in the treatment of peripheralvascular disease to increase or restore blood flow through asignificantly narrowed artery in a limb; it is also used in thetreatment of blockage of the coronary arteries. In fact, coronaryangioplasty has emerged as a major viable alternative to bypass surgeryfor revascularization of stenotic and occluded coronary arteries. Unlikebypass surgery, angioplasty does not require general anesthesia, openingof the chest wall, use of a heart-lung machine, or transfusion of blood.Angioplasty is not only less invasive and less traumatic to the patient,it is also less expensive because of the shorter hospital stay andshorter recovery time.

Transluminal balloon angioplasty is performed by first inserting ahollow needle through the skin and surrounding tissues and into thepatient's femoral artery. A guidewire is advanced through the hollowneedle and into the artery, then along the patient's vasculature towardthe site of the blocked blood vessel or heart valve to be treated. X-rayimaging is used to help move the guidewire through the vascular systemand into position just past the stenosis to be treated. A ballooncatheter is then threaded over the guidewire and advanced until thedeflated balloon is within the stenosis. The balloon is then repeatedlyinflated to widen the narrowed blood vessel. After the procedure iscomplete, the catheter and guidewire are withdrawn from the bloodvessels and the patient.

Angiography, which is used to detect diseases that alter the appearanceof blood vessels, is performed in a similar manner. A hollow needle isfirst inserted into the femoral artery and a guidewire is insertedthrough the needle and into the affected blood vessel. A catheter isthreaded over the guidewire and into the blood vessel. X-ray imaging isused to guide the catheter to a desired position. Contrast medium isthen injected, and a rapid sequence of x-ray pictures are taken so thatblood flow along the affected vessel can be studied. The catheter andguidewire are later removed from the patient's body.

After the catheter used during angioplasty or angiography are removed,the puncture wound in the femoral artery must be closed and the bleedingthrough the puncture site in the artery stopped. Currently, ice packsand/or pressure are applied to the area surrounding the wound for aperiod lasting up to several hours in an attempt to stop the bleeding.There exists, however, a significant chance that the wound will reopenand begin bleeding again when the patient moves. Another possiblecomplication is the development of a false aneurysm, which increases therisks of both infection and reopening.

Although efforts have been made to close the puncture wound usingstaples, clips, collagen plugs, and sutures, they have beenunsuccessful, largely due to the inability to see the puncture wound inthe femoral artery, and also because of the difficulty of controllablymodifying the artery in the limited space provided.

Other wounds in the vasculature of a patient can also be difficult tosee, and are thus difficult to locate, access and close. Thus, a deviceand method to facilitate locating and closing of such wounds in thevasculature of a patient would be extremely beneficial. A device havingthe ability to consistently and reliably locate, isolate and close thepuncture wound would eliminate the prolonged bleeding currentlyassociated with such wounds.

SUMMARY OF THE INVENTION

Accordingly, there is a need in the art for a device and method forprecisely locating a blood vessel wound and sealing the wound.

In accordance with one embodiment, an assembly for closing a bloodvessel wound is provided. An elongate catheter of the assemblyaccommodates a guidewire threaded therethrough. The catheter isconfigured to slide over the guidewire so that a tip of the catheterextends into a blood vessel wound. A hemostatic material comprises ahemostasis-facilitating agent. A push member is adapted to sliderelative to the catheter. The push member has a lumen adapted tocommunicate a flowable adhesive therethrough.

In accordance with another embodiment, an assembly is provided forclosing a vascular wound. A surgical implement is configured to extendat least partially through a vascular wound. A hemostatic materialmember comprises a hemostatic agent. A push member is configured to belongitudinally slidable relative to the surgical implement. The pushmember is adapted to engage and push the hemostatic materiallongitudinally over the surgical implement.

In accordance with yet another embodiment, an assembly is provided forlocating and sealing a vascular puncture. An elongate catheter has alumen sized and adapted to accommodate a guidewire threadedtherethrough. The catheter comprises a distal tip having a first outerdiameter and a puncture edge engagement portion proximal of the distaltip and having a second outer diameter greater than the first diameter.The catheter is configured to slide over the guidewire so that a portionof the catheter extends through the vascular puncture. The engagementportion engages edges of the puncture, and is sized to flex the punctureedges sufficient to substantially plug the puncture. A hemostatic spongeis positioned on the catheter proximal of the engagement portion, and isarranged so as to extend substantially circumferentially around an outersurface of the catheter. A retractor is selectively movable between aclosed position and an open position. The retractor is configured toengage the outer surface of the catheter when in the closed position andis configured when in the open position to enable the sponge to movelongitudinally over the catheter and through the open retractor. A pushmember is configured to engage the hemostatic sponge and push the spongedistally over the catheter.

For purposes of summarizing the preferred embodiments and the advantagesachieved over the prior art, certain embodiments and advantages havebeen described herein above. Of course, it is to be understood that notnecessarily all such advantages may be achieved in accordance with anyparticular embodiment. Thus, for example, those skilled in the art willrecognize that the invention may be embodied or carried out in a mannerthat achieves or optimizes one advantage or group of advantages astaught herein without necessarily achieving other objects or advantagesas may be taught or suggested herein.

The embodiments discussed above and other embodiments will becomereadily apparent to those skilled in the art from the following detaileddescription of the preferred embodiments having reference to theattached figures, the invention not being limited to any particularpreferred embodiment(s) disclosed.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a side view of an embodiment of a vascular closure apparatusshown assembled and ready for use.

FIG. 2 is a side view of a distal portion of the apparatus of FIG. 1.

FIG. 3 is a side view of a push member having features in accordancewith the present invention.

FIG. 4 shows the apparatus of FIG. 1 advanced over a guidewire into ablood vessel of a patient.

FIG. 5 shows the arrangement of FIG. 4 with the retractor arms open anda suction tool in use.

FIG. 6 shows the arrangement of FIG. 5, wherein a hemostatic sponge hasbeen advanced into contact with the blood vessel wall.

FIG. 7 shows the arrangement of FIG. 6, with the retractor arms removed.

FIG. 8 shows the arrangement of FIG. 7 with the catheter and guidewireremoved.

FIG. 9 shows the arrangement of FIG. 8, wherein a flowable adhesive isbeing delivered to the sponge.

FIG. 10 shows the arrangement of FIG. 8, wherein the push member isbeing removed from the patient.

FIG. 11 shows a sealed puncture wound after treatment with an embodimentof the device and method.

FIG. 12 shows an embodiment wherein an additional sponge is beingadvanced toward the wound.

FIG. 13 shows the embodiment of FIG. 12 with the additional sponge inplace.

FIG. 14 shows another embodiment of a hemostatic sponge member.

FIG. 15 shows the sponge member of FIG. 14 in contact with the vesselwall and having a catheter extending therethrough.

FIG. 16 shows the arrangement of FIG. 15 with the catheter removed.

FIG. 17 shows an embodiment in which a lock member is provided proximala hemostatic sponge member.

FIG. 18 shows a sealed puncture wound after treatment with the device ofFIG. 12.

FIG. 19 shows a schematic view of an unfolded two-layer patch.

FIG. 20 shows the patch of FIG. 19 in a folded position.

FIG. 21 shows the patch of FIG. 19 slidably mounted onto a catheter andbeing advanced by a push member.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

The present apparatus and method is especially useful for closingvascular puncture wounds that are difficult to access and/or visualize.It is difficult to directly and accurately modify the wounded bloodvessel in order to close such wounds. Additionally, there are pitfallsassociated with directly modifying the blood vessel. For example, sincethe clinician cannot see the wound, it is difficult to correctly placeclosure media such as sutures, staples, or clips. Incorrect placement ofsuch closure media likely results in inadequate closure; the puncturewound remains open, perhaps without the clinician being aware.Additionally, incorrect placement of closure media may cause permanentdamage to the vessel, including tearing and additional puncture wounds.Further, if closure media extends through the wound and into the bloodflow, this media can increase the likelihood of thrombus formation orcould introduce potentially toxic substances into the bloodstream. Ofcourse, closure media inadvertently released into the bloodstream couldlead to serious blood vessel blockage complications.

With reference to FIG. 1, a vascular wound closure assembly 30 includesan elongate catheter 32 having a distal end 34 and a proximal end 36 ofthe catheter 32. A distal opening 38 is formed through the distal end 34of the catheter 32 and opens along a longitudinal axis of the catheter32. The catheter 32 includes a tapered tip 40 at the distal end 34. Anelongate main body 42 of the catheter 32 is disposed proximal thetapered tip 40. Preferably the main body 42 has a substantially uniformdiameter along its length. A lumen 44 extends longitudinally within thecatheter 32 from the distal opening 38 to the proximal end 36.

A connector portion 46 is provided on the proximal end 36. The connectorportion 46 includes a main lumen 48 and a secondary lumen 50. The mainlumen 48 extends along the longitudinal axis of the catheter 32 and iscoextensive with the catheter lumen 44. The secondary lumen 50 extendsoutwardly from the main lumen 48, but communicates with the main lumen48 and the catheter lumen 44. A proximal opening 52 is provided at theproximal end of the main lumen 48 and, like the distal opening 38, opensalong the longitudinal axis. A secondary opening 54 opens into thesecondary lumen 50.

The distal and proximal openings 38, 52 are sized and adapted toaccommodate a guidewire 58 such as the guidewire used in angioplasty andother vascular surgeries. As such, the guidewire 58 can be threadedthrough the catheter 32 and the catheter can be advanced over theguidewire 58.

Holes 60 are formed through a side wall of the catheter 32 near thedistal end 34 of the catheter 32. Preferably, at least two holes 60 areprovided. All of the holes 60 preferably are disposed substantially thesame distance from the distal end 34 of the catheter 32. Preferably, araised portion 62 of the catheter 32 is provided in the region aroundthe holes 60, which region is proximal of the tip 40 and distal of themain body 42. At the raised portion 62, the catheter 32 has an outerdiameter that is slightly larger than the outer diameter throughout thecatheter main body 42.

With continued reference to FIG. 1, a vacuum or other source of suction64 is provided and communicates, through tubing 66, with the secondarylumen 50 of the catheter connector portion 46. Thus, a vacuum is drawnthrough the catheter lumen 44. Preferably, the distal and proximalopenings 38, 52, which accommodate the guidewire 58, are sized so thatthe guidewire 58 substantially plugs the openings; thus, the vacuum isdrawn through the holes 60. A viewing port 68 is arranged between thesource of suction 64 and the catheter 32. The viewing port 68 isconfigured to allow a clinician to view the material that is drawn bysuction through the holes 60 and through the catheter lumen 44. Theviewing port 68 will be discussed in more detail below.

With reference to FIGS. 1 and 2, a retractor 70 is preferably mounted onthe catheter 32. The retractor 70 includes opposing elongate retractorarms 72 that are aligned longitudinally on the catheter 32. A retractorbody 74 is configured to selectively open and close the retractor arms72 when operated by a clinician. The elongate retractor arms 72 of theretractor 70 are positioned on the catheter 32 so that distal ends 76 ofthe arms are positioned proximal of the catheter holes 60 a distancethat is at least the same as the width of an artery wall, preferably atleast about 0.5 to 2 millimeters.

With reference again to FIG. 1, a hemostatic member 80 is arranged onthe catheter 32 proximal of the retractor 70. As will be discussed inmore detail below, the hemostatic member comprises a material that ismade of or includes a hemostatic agent. The hemostatic agent is adaptedto aid blood clotting. In one embodiment, the hemostatic member 80comprises a sponge or sponge-like material. In this description, spongeis a broad term that is used in accordance with it ordinary meaning andincludes, without limitation, a material that is adapted to soak up atleast a portion of blood that may come in contact with the material.

For purposes of this description, the hemostatic member 80 is referredto as the sponge 80. However, it is to be understood that use of theterm “sponge” does not limit the scope of materials that can be used asthe hemostatic member. In fact, any material that aids or facilitatesblood clotting can be used as the hemostatic member.

Preferably, the sponge 80 extends circumferentially around the cathetermain body 42, and is arranged so that it can be slid longitudinallyalong the catheter 32. Most preferably, the catheter 32 extends througha passageway 82 through the sponge 80. The passageway 82 is formed asthe catheter 32 is forced through the sponge 80.

A push member 84 is also arranged on the catheter 32 distal of thesponge 80. With reference also to FIG. 3, the push member 84 comprises abody portion 86 and a proximal handle portion 88. An elongate lumen 90is formed through the body portion 86. As shown in FIG. 1, the lumen 90preferably encircles the catheter 32 so as to allow the push member 84to slide relative to the catheter 32. A plurality of holes 92 are formedthrough the body portion 86 at a point near the distal end of the pushmember 84.

As will be discussed in more detail below in connection with FIG. 4, thevascular wound closure assembly 30 enables a clinician to preciselylocate a subcutaneous vascular wound “w”, access the wound w, anddeliver the hemostatic sponge 80 to the wound site. The hemostaticsponge 80 includes a hemostatic agent that helps facilitate closure ofthe wound w.

In order to properly apply the hemostatic sponge 80, the vascularclosure assembly 30 first precisely locates and provides access to thevascular wound w. It is to be understood that the present method andapparatus can be used to close various vascular and other wounds. FIGS.1-11, and the accompanying discussion, present an example using anembodiment to close a puncture wound w in a patient's femoral artery 94.

With specific reference to FIGS. 1, 2, 4 and 5, in order to preciselylocate and provide access to a femoral artery puncture wound w, thecatheter 32 is first threaded over a guidewire 58 that has beenpreviously inserted into the patient's femoral artery 94 through thepuncture wound w. The lumen 44 is attached to the source of suction 64and the assembly 30 is advanced over the guidewire 58 through apatient's tissue 96 so that the distal tip 40 of the catheter 32 extendsthrough the vascular puncture wound w.

As the assembly 30 is advanced, the source of suction 64 draws bodilyfluids through the holes 60. The fluids pass through the viewing port68, which allows the clinician to identify the fluids being withdrawn.The viewing port 68 can have any suitable structure or location. Forexample, the viewing port can comprise clear tubing attached to thecatheter, a substantially transparent syringe that functions as both asource of suction and a viewing port, or a portion of the catheter thatis substantially transparent. Most preferably, the catheter 32 is formedof a transparent material so that the clinician becomes aware as soon asblood begins to be drawn through the catheter.

When the holes 60 pass the artery wall 98 and enter the blood vessel 94,as shown in FIG. 4, blood “b” begins to be drawn through the holes 60into the catheter 32 and is conducted past the viewing port 68. Thus,when blood b is observed in the viewing port 68, the clinician will knowthat the holes 60 have just passed into the puncture wound w and thatthe distal ends 76 of the retractor arms 72 are thus positioned adjacentthe outer wall 98 of the artery 94, preferably within about 2 mm of theartery wall 98. The retractor arms 72 are then separated as shown inFIG. 5, thus drawing surrounding tissue 96 away from the wound w andcreating a field 100 around the puncture wound w. The catheter 32remains disposed partially within the puncture wound w, effectivelyplugging the wound and preventing blood from flowing through the wound.The raised portion 62 flexes the edges of the wound w to enhance theseal between the catheter 32 and the puncture wound edges.

With continued reference to FIG. 5, a suction tool 102 can be used toclear away bodily fluids and other matter that may be within the field100 and to clean the wall 98 of the blood vessel 94 adjacent thepuncture wound w.

With reference next to FIG. 6, once the puncture wound w has beenprecisely located, the push member 84 is advanced distally along thecatheter 32, thus advancing the sponge 80 into contact with the vesselwall 98 so as to surround the puncture wound w. As mentioned above anddiscussed in more detail below, the sponge 80 comprises a hemostaticagent that will help accelerate blood clot formation at the wound site win order to help the wound heal faster.

With particular reference to FIGS. 1 and 6, in the illustratedembodiment an outer diameter of the push member 84 at its distal end ismuch less than an outer diameter of the sponge 80. As such, the distalend of the push member 84 engages only a comparatively small portion ofthe proximal side of the sponge 80 when advancing the sponge 80 over thecatheter 32 toward the wound. Nevertheless, as shown in FIG. 6, thesponge 80 preferably is comprised of a material that is generallycohesive so that the sponge 80 remains generally intact and moves as aunit as it is advanced over the catheter 32. As such, the push member 84can advance the entire sponge 80 as a unit even though it contacts onlya portion of one side of the sponge 80.

Preferably, the sponge 80 is at least partially coated with an adhesiveso that the sponge will at least partially bond to the vessel wall 98.Alternatively, or in addition, flowable adhesive can be delivered intothe field around the puncture wound before the sponge is advanced intocontact with the vessel wall. Of course, the sponge can be deliveredwithout using any adhesive.

The sponge 80 is preferably mounted onto the catheter 32 so as tosubstantially encircle the catheter 32. Thus, since the tip 40 of thecatheter is disposed in the wound, the sponge 80 substantially surroundsthe wound w when the sponge is positioned adjacent the vessel wall 98.When the sponge 80 is in place adjacent the wound w, the retractor 70can be removed, as shown in FIG. 7. When the retractor 70 is removed,the surrounding body tissues 96 collapse around the sponge 80 and pushmember 84. The push member 84 holds the sponge 80 in position while bodytissue 96 surrounds the sponge 80 and while the adhesive cures.

With reference next to FIG. 8, with the push member 84 in place, thecatheter 32 and guidewire 58 can also be removed from the patient. Thepassage 82 through the sponge 80, which had been occupied by thecatheter 32, collapses onto itself so that it is substantially closed.The vessel wound w is no longer plugged by the catheter 32, and it isanticipated that blood b from the vessel 94 will flow into the sponge80, at least partially soaking the sponge 80. Although the retractor 70is removed prior to the catheter 32 in the above-discussed embodiment,it is to be understood that, in another embodiment, the catheter may beremoved prior to the retractor.

In still another embodiment, additional pressure can be applied to thepush member 84 in order to at least partially block blood flow throughthe blood vessel 94. In this manner, the clinician can control howquickly blood will flow through the wound w and into the sponge 80. Ofcourse, other methods and apparatus can be used to temporarily reduce orstop blood flow through the vessel.

In a preferred embodiment, the sponge 80 comprises a material made of orsoaked in a hemostatic agent. The agent is specially adapted to aidblood clotting. Thus, blood that flows into the sponge will quicklybecome clotted, causing natural sealing of the wound through bloodclotting. Sponge-like hemostasis agents are available and can includeproducts such as Gelfoam™, Oxycell™ and Avitene™. Other appropriatehemostatic sponges may be impregnated with thrombin, a liquid clottingagent, to help accelerate blood clot formation. Another material thatmay advantageously be used is a collagen Ultrafoam™ sponge marketed byC.R. Bard/Davol, Inc. The Ultrafoam™ sponge is made from Avitene™collagen, a natural clotting agent, and does not require the addition ofthrombin. This reduces preparation time and the risk that a patient willexperience a potentially hazardous reaction to bovine thrombin. Othermedicants can also be included in the sponge. For example, antibioticmedicines, anti-inflammatory drugs, healing aids, and the like can beimpregnated into the sponge material.

The sponge-like material is preferably soft and pliable and will conformto the structure of the blood vessel, the wound and the field around theblood vessel. Thus, the sponge-like material is specially suited for usein the confined space surrounding a vascular puncture. Additionally, thehemostatic sponge 80 will be held in place by the tissue 96 surroundingthe puncture wound w, which tissue 96 collapses over the sponge 80 whentools such as the retractor 70 are removed.

To further help hold the sponge 80 in place, flowable adhesive 106 froma source of adhesive 108 can be delivered through the lumen 90 of thepush member 84 and onto the sponge 80, as shown in FIG. 9. The adhesive106 flows through the open distal end of the push member 84 and alsothrough the holes 92 through the push member body portion 86. Uponcuring, the adhesive 106 can form a sealing layer around and within thesponge 80, thus confining the blood b to the sponge area. This helpsminimize bleeding and even further speeds clot formation. Addingadhesive 106 will also facilitate more complete closure of the passagethrough the sponge, which passage was vacated by the catheter 32.Further, the adhesive 106 will help hold the sponge 80 in place relativeto the puncture wound w and the surrounding tissue 96.

As discussed above, prior to being advanced into contact with the bloodvessel wall, the sponge 80 may be soaked in an adhesive or, morepreferably, coated with a layer of adhesive. In this manner, adhesivedistribution on the sponge can be controlled. By controllably applying acoating of adhesive around the outer surface of the sponge, the adhesivewill bond the sponge to the area surrounding the blood vessel wound w,including the vessel 94 itself, and also can form a perimeter seal ofthe sponge when the adhesive cures. The coating of adhesive can act as amembrane confining the blood b to the sponge 80. It is to be understoodthat a coating of adhesive may be used instead of or in addition toapplying additional adhesive 106 through the push member 84.

Various kinds of flowable adhesives may be acceptable for use with thesponge. For example, fibrin tissue sealants such as Tisseel®, which isavailable from Baxter Healthcare Corp., may be appropriate. Othercommercially available adhesives that may be appropriate includeBioglue™, available from Cryolife, Inc., and Floseal™, which isavailable from Fusion Medical Technologies. Various cyanoacrylateadhesives are currently commercially available and can be used with thisinvention. Of course, any product that is capable of sealing the spongeor at least retarding blood flow through or beyond the sponge would beacceptable. It is also to be understood that certain adhesives will notrequire that the field and/or the outer wall of the blood vessel becleared before the adhesive is injected.

Curing time and ease of use will vary depending on the adhesive used.For example, some adhesives cure to a malleable gel-like state within afew seconds, while others will cure directly to a hardened state in afew minutes. The time period for curing is chosen to allow the clinicianto advance the sponge into position adjacent the wound and in contactwith the artery, at which time the sponge will begin to be bonded to thevessel wall and substantially sealed by the adhesive. It should beappreciated that any acceptable adhesive having any acceptable curingtime may be used.

The push member 84 may be kept in place for any reasonable time periodin order to allow the adhesive 106 to cure. Also, multiple sponges canbe used, if desired. Preferably, however, the adhesive 106 will curesufficiently in about five minutes or less. Other tools, such as anultraviolet light source or a heat application device, may be used tohelp speed adhesive curing.

Once the sponge 80 is correctly placed, the push member 84 can beremoved. Removal of the push member 84 can be aided by a release rod 110which, as shown in FIG. 10, is advanced through the push member lumen 90and into contact with the sponge 80. The release rod 110 holds thesponge 80 in place as the push member 84 is withdrawn from the patient.Thus, the release rod 110 engages the sponge 80 so as to provide countertraction when the push member 84 is withdrawn. In this way, the pushmember 84 can be removed even if some adhesion occurs between the sponge80 and the push member 84. With reference next to FIG. 11, once therelease rod 110 is withdrawn, the patient's skin 112 is closed by anyappropriate closure media such as, for example, sutures 114. Thehemostatic sponge 80 is left in place. The body's natural blood clottingprocess will plug and repair the vascular wound w with the aid of thehemostatic sponge 80. Thus, healing will proceed without the danger offalse aneurysms, missed or faulty wound closure, or the like.

As discussed above and shown in FIGS. 1 and 7, the hemostatic sponge 80circumferentially surrounds the catheter 32, and the catheter 32preferably extends through a puncture hole 82 through the sponge 80.When the catheter 32 is removed, however, the hole 82 remains. Spongesthat are relatively elastic will spring back into place, filling thehole 82. However, some hemostatic sponge materials have relatively poorelastic resilience and mechanical strength. Such materials may not beable to spring back into place to fill the hole. This is problematicbecause the hole 82 is aligned with the blood vessel wound w; thus,blood b may flow substantially unimpeded through the hole 82, possiblyleading to complications. Also, adhesive that is injected can possiblyflow through the hole 82 in the sponge 80 and further through the woundw and into the bloodstream.

Accordingly, in another embodiment depicted in FIGS. 12 and 13, therelease rod 110 can be used to advance one or more additional hemostaticmembers 118 through the push member lumen 90 and into contact with theoriginal sponge 80. The additional sponge material 118 can help furtherplug the hole 82 in the sponge 80 through which the catheter 32 wasdisposed, and will stem the flow of blood b with the hemostatic spongematerial 118, which will facilitate blood clotting. The additionalsponge material 118 will also plug the hole 82 left in the originalsponge 80 so that adhesive that may be added later will be blocked fromentering the wound w.

With reference next to FIGS. 14-16, another embodiment of a hemostaticsponge member 120 comprises a hemostatic sponge layer 122 and a highlyelastic layer 124. A layer of cement 126 attaches the hemostatic layer122 to the elastic layer 124. Alternatively, the hemostatic layer 122and elastic layer 124 can be integrally formed. As with the hemostaticsponge 80 described above, the hemostatic layer 122 comprises ahemostatic agent which facilitates and speeds blood clotting. Theelastic layer 124 improves the overall elasticity and mechanicalstrength of the sponge 120. Preferably the elastic layer 124 comprises apolymer having relatively high elastic resilience and mechanicalstrength. Polymer elastomers such as polyurethane, SDS and siliconrubber can advantageously be used for the elastic layer 124. It is to beunderstood that the elastic layer 124 preferably is non-toxic. Also, itis not necessary for the elastic layer to include a hemostasis agent orany other medicament.

As discussed above, the catheter 32 preferably extends through apuncture hole 82 through the hemostatic sponge 120. With continuedreference to FIG. 15, the elastic layer 124 is preferably oriented on aside of the sponge 120 away from the wound w, while the hemostaticsponge layer 122 is oriented so as to directly contact the blood vesselwall 98 and wound w. With specific reference to FIG. 16, when thecatheter 32 is removed from the hemostatic sponge 120, the highlyelastic layer 124 will immediately retract, substantially sealing thehole 82. Since the hemostatic sponge layer 122 is connected to theelastic layer 124, the sponge material 122 will also be retracted,closing the hole. Accordingly, not only will the hole be sealed, but thehemostatic material 122 will fill the hole 82 so as to be placeddirectly in the path of blood b coming from the vascular wound w.Accordingly, more thorough and speedier blood clotting is achieved.

In the embodiment illustrated in FIGS. 1-9, the catheter comprises asingle-lumen catheter. In another embodiment (not shown), the elongatecatheter has a first lumen comprising a tube that extends from thedistal end opening to the proximal end opening and slidinglyaccommodates the guidewire therewithin. The outer wall of the catheterdefines a second lumen that concentrically surrounds the first lumen.The holes through the outer wall of the catheter open into the secondlumen. Additionally, an access lumen communicates with the second lumen.In this embodiment, the distal and proximal openings, which accommodatethe guidewire, do not communicate with the second lumen, which lumencommunicates with the source of suction through the access lumen.Accordingly, in this embodiment, there may be less of a chance that bodyfluids will be drawn into the catheter through the distal and proximalguidewire openings than in an embodiment employing a single lumen.However, the single-lumen catheter can be less expensive to manufactureand can be expected to have a smaller diameter than the dual-lumencatheter.

Portions of the above-described embodiments share certain aspects withthe apparatus disclosed in U.S. application Ser. No. 09/325,982, filedon Jun. 4, 1999, now U.S. Pat. No. 6,287,322, which is herebyincorporated by reference in its entirety. FIGS. 28-31 and 48-50 of U.S.Pat. No. 6,287,322 show some embodiments of retractors and a catheterthat may be used in accordance with certain embodiments.

FIG. 17 shows another additional embodiment wherein a lock apparatus 130is employed to help hold the sponge 80 in place against the artery wall98. The lock apparatus 130 is preferably slidably disposed about thecatheter 32 between the push member 84 and the sponge 80. The lockapparatus 130 accompanies the sponge 80 as it is advanced into positionon the blood vessel wall 98 surrounding the vascular wound w. The lockapparatus 130 has arms that preferably are configured to allow movementthrough tissue 96 toward the wound w, but resist movement of theapparatus 130 in the direction away from the wound w. Thus, the lockapparatus 130 holds the sponge 80 tightly in place adjacent the wound wshown in FIG. 18.

It is to be understood that several forms of the lock apparatus may beadvantageously employed. For example, in the illustrated embodiment, thelock apparatus 130 has swept-back arms 132 that are adapted so that theapparatus 130 can be advanced through a tissue 96 toward the vascularwound w, but cannot be moved away from the vascular wound w because thearms 132 will engage the surrounding tissue 96. In another embodiment,selectively actuable arms may be provided within the lock apparatus. Atrigger may be provided so that the arms will extend into thesurrounding tissue when the trigger is actuated, thus locking the devicein place and holding the sponge next to the vascular wound.

The lock apparatus is preferably formed of a material that can beabsorbed by the body over time. However, other materials, such asstainless steel, can be advantageously used.

In a further additional embodiment illustrated in FIGS. 19-21, amulti-layer patch 140 is used in addition to or instead of the sponge80. The patch 140 may be soaked or coated with a hemostatic agent and/oradhesive and is specially adapted to be advancable over the catheter 32and to cover the vascular wound w. As shown in FIG. 19, the patch 140preferably comprises a single piece of material 142 having a fold line144 disposed roughly down the middle thereof. A first slit 146 isprovided in a first half 148 of the patch 140 and a second slit 150 isprovided in a second half 152 of the patch 140. Preferably, the secondslit 150 is substantially normal to the first slit 146. The patchmaterial 142 is folded over itself as shown in FIG. 20 and is threadedover the catheter 32 as shown in FIG. 21. The catheter 32 fits througheach of the slits 146, 150, which provide room for the catheter 32 toslidingly fit therethrough. However, as the patch 140 is advanced intoposition and the catheter 32 is removed from the patch, the slits 146,150 overlap each other, leaving only a small hole, if any. Adhesive canbe applied over the small hole and/or between the halves to ensuresealing of the patch and closure of the wound.

A number of other embodiments may be employed that combine variousaspects that have been discussed above. For example, the multi-layerpatch 140 of FIG. 17 may be bonded to the artery wall 98 using anadhesive applied to the base of the patch and then a sponge may beadvanced over the patch, or vice versa. Additionally, rather than thetwo-arm retractor 70 disclosed herein, other means may be used forproviding access to the blood vessel 94. For instance, access andlocation may be provided by a cannula, balloon, or the like. Stillfurther, in some embodiments, an elastic and conformable sponge can bepositioned adjacent the wound by being advanced over the catheter, oreven over a bare guidewire, without using any additionalaccess-providing device.

Although this invention has been disclosed in the context of certainpreferred embodiments and examples, it will be understood by thoseskilled in the art that the present invention extends beyond thespecifically-disclosed embodiments to other alternative embodimentsand/or uses of the invention and obvious modifications and equivalentsthereof. In addition, while a number of variations have been shown anddescribed in detail, other modifications, which are within the scope ofthis invention, will be readily apparent to those of skill in the artbased upon this disclosure. It is also contemplated that variouscombinations or subcombinations of the specific features and aspects ofthe embodiments may be made and still fall within the scope of theinvention. Accordingly, it should be understood that various featuresand aspects of the disclosed embodiments can be combined with orsubstituted for one another in order to form varying modes of thedisclosed modular arrangement and method. Thus, it is intended that thescope of the present invention should not be limited by the particulardisclosed embodiments described above, but should be determined only bya fair reading of the claims that follow.

What is claimed is:
 1. An assembly for locating and closing a vascularpuncture, comprising: an elongate, unitary catheter having a lumen sizedand adapted to accommodate a guidewire threaded therethrough, thecatheter comprising a distal tip having a first outer diameter and anon-inflatable puncture edge engagement portion proximal of the distaltip and having a second outer diameter greater than the first diameter,the catheter being generally tapered from the distal tip to theengagement portion, the catheter configured to slide over the guidewireso that a portion of the catheter extends through the vascular punctureand the engagement portion engages edges of the puncture and urges suchedges radially outwardly, the engagement portion sized to flex thepuncture edges radially outwardly sufficient to substantially plug thepuncture; a hemostatic sponge positioned on the catheter entirelyproximal of the engagement portion and arranged so as to extendsubstantially circumferentially around an outer surface of the catheter;a retractor selectively movable between a closed position and an openposition, the retractor configured so that when in the closed positionportions of the retractor on opposing sides of the catheter engage theouter surface of the catheter sufficient so that the catheter andretractor move together when the retractor is closed upon the catheter,the retractor additionally configured when in the closed position toprevent distal movement of the sponge longitudinally over the catheterand past the retractor, the retractor further configured when in theopen position to enable the sponge to move longitudinally over thecatheter and through the open retractor; and a push member configured toengage the hemostatic sponge and push the sponge distally over thecatheter when the retractor is in the open position.
 2. The assembly ofclaim 1, wherein the retractor has a plurality of elongate retractorarms, the retractor arms being movable between a closed position and anopen position.
 3. The assembly of claim 2, wherein the retractor isconfigured so that, when the retractor arms are in the opened position,an access passage is defined between the arms, the access passage sizedso that the hemostatic sponge and the push member can slidetherethrough.
 4. The assembly of claim 1, wherein the hemostatic spongeand the push member are mounted onto the catheter so as to slidelongitudinally over the catheter, and the hemostatic sponge is mounteddistally of the push member.
 5. The assembly of claim 4, wherein thesponge is mounted onto the catheter at a position that is proximal ofthe retractor arms.
 6. The assembly of claim 4, wherein the spongecomprises an absorbent material adapted to soak up blood.
 7. Theassembly of claim 6, wherein the sponge is adapted to aid bloodclotting.
 8. The assembly of claim 4, wherein the hemostatic sponge isgenerally cohesive so that when the push member engages and pushes ononly a portion of one side of the sponge, the entire sponge movesdistally over the catheter as a cohesive unit.
 9. The assembly of claim8 additionally comprising an elongate release rod having a distal enddisposed proximal of the sponge, wherein the push member comprises anelongate lumen, and the rod is configured to slidably fit through thepush member lumen into engagement with the sponge.
 10. The assembly ofclaim 1, wherein the push member comprises an elongate body and aproximal handle portion, and a longitudinal lumen is formed through thepush member.
 11. The assembly of claim 10 additionally comprising anelongate release rod having a distal end disposed proximal of thesponge, the rod configured to slidably fit through the push member lumenand into engagement with the sponge.
 12. The assembly of claim 10,wherein the push member body has a plurality of holes formed through aside wall thereof near a distal end of the body.
 13. The assembly ofclaim 12, wherein the push member lumen is adapted to be attached to asource of flowable adhesive.
 14. The assembly of claim 1, wherein thehemostatic sponge comprises a first layer attached to a second layer,the first layer having greater elasticity than the second layer.
 15. Theassembly of claim 14, wherein the first and second layers are attachedto each other by a cement.
 16. The assembly of claim 14, wherein thefirst and second layers are integrally formed.
 17. The assembly of claim14, wherein the hemostatic sponge is configured so that a puncture holethrough the first and second layers is substantially sealingly closed bythe elastic first layer.
 18. The assembly of claim 17, wherein thecatheter extends through a puncture hole formed through the first andsecond layers.
 19. The assembly of claim 1, wherein the sponge is coatedwith an adhesive.
 20. The assembly of claim 1, wherein the spongecomprises an anti-inflammatory drug.
 21. The assembly of claim 1,wherein the sponge comprise an antibiotic.
 22. The assembly of claim 1,wherein the push member comprises a lumen adapted to communicate aflowable adhesive therethrough.
 23. The assembly of claim 1, wherein thecatheter is attachable to a source of suction, and a hole is formedthrough a wall of the catheter near a distal end of the lumen.
 24. Theassembly of claim 1, wherein the push member is sized and configured tourge the sponge over the catheter from a position proximal of theretractor to a distal end of the retractor.
 25. The assembly of claim 1,wherein the sponge is not compressed within a housing.
 26. An assemblyfor locating and closing a vascular puncture, comprising: an elongatecatheter having a lumen sized and adapted to accommodate a guidewirethreaded therethrough, the catheter comprising a distal tip having afirst outer diameter and a puncture edge engagement portion proximal ofthe distal tip and having a second outer diameter greater than the firstdiameter, the catheter configured to slide over the guidewire so that aportion of the catheter extends through the vascular puncture and theengagement portion engages edges of the puncture, the engagement portionsized to flex the puncture edges sufficient to plug the puncture; ahemostatic sponge positioned on the catheter proximal of the engagementportion and arranged so as to extend substantially circumferentiallyaround an outer surface of the catheter; a retractor selectively movablebetween a closed position and an open position, the retractor configuredto engage the outer surface of the catheter when in the closed positionand configured when in the open position to enable the sponge to movelongitudinally over the catheter and through the open retractor; a pushmember configured to engage the hemostatic sponge and push the spongedistally over the catheter; and means for engaging body tissues proximalof the sponge so as to prevent the sponge from moving in a directionaway from the vascular puncture once the sponge is installed on an outersurface of a vascular vessel at or adjacent the puncture, wherein themeans comprises swept-back arms, and wherein the means is formedseparately from the sponge, more rigid than the sponge, and is held inplace by the tissues directly proximal of the sponge and the means. 27.An assembly for locating and closing a vascular puncture, comprising: anelongate catheter having a lumen sized and adapted to accommodate aguidewire threaded therethrough, the catheter comprising a distal tiphaving a first outer diameter and a puncture edge engagement portionproximal of the distal tip and having a second outer diameter greaterthan the first diameter, the catheter configured to slide over theguidewire so that a portion of the catheter extends through the vascularpuncture and the engagement portion engages edges of the puncture, theengagement portion sized to urge the edges radially outwardly so as toflex the puncture edges sufficient to substantially plug the puncture; ahemostatic sponge positioned on the catheter proximal of the engagementportion and arranged so as to extend substantially circumferentiallyaround an outer surface of the catheter; a retractor selectively movablebetween a closed position and an open position, the retractor configuredto engage and mount upon the outer surface of the catheter when in theclosed position sufficient so that the catheter and retractor movetogether as a unit, and so as to prevent distal movement of the spongepast the retractor, and configured when in the open position to enablethe sponge to move longitudinally over the catheter and through the openretractor; a push member configured to engage the hemostatic sponge andpush the sponge distally over the catheter, the push member comprisingan elongate body and a proximal handle portion, and a longitudinal lumenis formed through the push member; and an elongate release rod having adistal end disposed generally proximal the sponge, the rod configured toslidably fit through the push member lumen so that its distal endengages the sponge.
 28. The assembly of claim 27, wherein the retractorhas a plurality of elongate retractor arms, the retractor arms beingmovable between a closed position and an open position.
 29. The assemblyof claim 28, wherein the retractor is configured so that, when theretractor arms are in the opened position, an access passage is definedbetween the arms, the access passage sized so that the hemostatic spongeand the push member can slide therethrough.
 30. The assembly of claim28, wherein the hemostatic sponge and the push member are mounted ontothe catheter so as to slide longitudinally over the catheter, and thehemostatic sponge is mounted distally of the push member.
 31. Theassembly of claim 30, wherein the sponge is mounted proximal of theretractor arms.
 32. The assembly of claim 28, wherein the hemostaticsponge is generally cohesive so that when the push member engages andapplies a force to only a portion of one side of the sponge, the entiresponge moves distally over the catheter as a cohesive unit.
 33. Theassembly of claim 27, wherein the hemostatic sponge comprises a firstlayer attached to a second layer, the first layer having greaterelasticity that the second layer.
 34. An assembly for locating andclosing a vascular puncture, comprising: an elongate catheter having alumen sized and adapted to accommodate a guidewire threadedtherethrough, the catheter comprising a distal tip having a first outerdiameter and a puncture edge engagement portion proximal of the distaltip and having a second outer diameter greater than the first diameter,the catheter configured to slide over the guidewire so that a portion ofthe catheter extends through the vascular puncture and the engagementportion engages edges of the puncture, the engagement portion sized tourge the edges radially outwardly so as to flex the puncture edgessufficient to substantially plug the puncture; a hemostatic spongepositioned on the catheter proximal of the engagement portion andarranged so as to extend substantially circumferentially around an outersurface of the catheter; a retractor selectively movable between aclosed position and an open position, the retractor configured to engagethe outer surface of the catheter when in the closed position sufficientso that the retractor and catheter move together as a single assemblywhen the catheter is closed upon the catheter, and configured when inthe open position to be unattached to the catheter and defining a spacesufficient to enable the sponge to move longitudinally over the catheterand through the open retractor; and a push member configured toreleasably engage the hemostatic sponge and push the sponge distallyover the catheter, the push member comprising an elongate body, aproximal handle portion, and a longitudinal lumen formed therethrough,the push member positioned so as to releasably engage the sponge with adistal end of the push member body; wherein the push member body has aplurality of holes formed through a side wall thereof near but proximalof the distal end of the body; wherein the hemostatic sponge isgenerally cohesive so that when the push member body distal end engagesand applies a force to only a portion of one side of the sponge, theentire sponge moves distally over the catheter as a cohesive unit, andat least a portion of the sponge remains distal of the push member bodydistal end; and wherein the holes formed through the side wall of thepush member body are arranged so as to be proximal of the hemostaticsponge when the push member body distal end engages and applies a forceto the hemostatic sponge.
 35. The assembly of claim 34, wherein the pushmember lumen is adapted to be attached to a source of flowable adhesive.36. The assembly of claim 35, wherein the hemostatic sponge comprises afirst layer attached to a second layer, the first layer having greaterelasticity that the second layer.
 37. The assembly of claim 34, whereinthe hemostatic sponge and the push member are mounted onto the catheterso as to slide longitudinally over the catheter, and the sponge ismounted proximal of the retractor arms.
 38. The assembly of claim 37additionally comprising an elongate release rod having a distal enddisposed generally proximal of the sponge, the rod configured toslidably fit through the push member lumen into engagement with thesponge.
 39. An assembly for locating and closing a vascular puncture,comprising: an elongate catheter having a lumen sized and adapted toaccommodate a guidewire threaded therethrough, the catheter configuredto slide over a guidewire so that a portion of the catheter extendsthrough the vascular puncture and engages edges of the puncture; aretractor selectively movable between a closed position and an openposition, the retractor sized and configured to engage at least aportion of an outer surface of the catheter on opposing sides when inthe closed position so that there is no space between the retractor andthe catheter, and configured to provide a space between the catheter andthe retractor when in the open position; a hemostatic sponge positionedon the catheter and arranged so as to extend substantiallycircumferentially around the outer surface of the catheter; a pushmember configured to engage the hemostatic sponge and push the spongedistally over the catheter, the push member comprising an elongate bodyhaving a proximal end and a distal end, a longitudinal lumen extendingfrom the proximal end to the distal end of the body, the sponge having agreater diameter than the push member so that the push member engagesonly a portion of a side of the sponge; and an elongate release rodhaving a distal end disposed generally proximal the sponge, the rodconfigured to slidably fit through the push member lumen to engage itsdistal end with the sponge; wherein the hemostatic sponge is generallycohesive so that when the push member engages and pushes on only aportion of one side of the sponge, the entire sponge moves distally overthe catheter as a cohesive unit; and wherein the push member andhemostatic sponge are disposed substantially proximal of the retractorwhen the retractor is in the closed position, and the push member andhemostatic sponge may only be advanced distally past the retractor whenthe retractor is in the open position.
 40. The assembly of claim 39,wherein the catheter comprises an engagement portion adapted to engageedges of the puncture without being inflated, the uninflated engagementportion sized to flex the puncture edges sufficient to substantiallyplug the puncture.
 41. The assembly of claim 40, wherein the cathetercomprises a distal tip having a first outer diameter, and the engagementportion is proximal the distal tip and has a second diameter that isgreater than the first diameter.
 42. The assembly of claim 39, whereinthe retractor has a plurality of elongate retractor arms, the retractorarms being movable between a closed position and an open position. 43.The assembly of claim 42, wherein the retractor is configured so that,when the retractor arms are in the opened position, an access passage isdefined between the arms, the access passage sized so that thehemostatic sponge and the push member can slide therethrough.
 44. Theassembly of claim 39, wherein the hemostatic sponge and the push memberare mounted onto the catheter so as to slide longitudinally over thecatheter, and the hemostatic sponge is mounted distally of the pushmember.
 45. The assembly of claim 44, wherein the sponge is mountedproximal of the retractor arms.